Sterility Assurance Specialist 2nd Shift

This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM - 10:30 PM. This is a set, consistent schedule based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

What the Sterility Assurance Specialist Does Each Day:

• Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Schedule & Proctor Media Fills
• Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units
• Performs EM/PM sampling; Maintains EM/PM records
• Periodically reviews Environmental/Personnel monitoring data to identify any potential trends
• Providing training support for personnel on appropriate aseptic techniques and gowning techniques including execution of Compounder Competency Assessments
• Provides support for sterility investigations including EM/PM excursions and review of deviations and investigations
• Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)
• Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
• Provides an established technical expertise for current processes and oversees training of department personnel on new processes
• Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products
• Evaluation of batches / product for compliance with defined specifications
• Sampling, inspection, and control of commercial product labels
• Review and approval of shipping documentation for commercial products

Our Most Successful Sterility Assurance Specialists:

• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility
• Are detail-oriented with strong verbal and written communications skills
• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
• Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions
• Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment
• Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback

Minimum Requirements for this Role:

• A High School diploma or equivalent
• Able to successfully complete a drug and background check
• Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
• 18+ years of age
• Strong Microsoft Word and Excel skills
• Knowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for Sterile Product
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Bachelor's Degree in life science or related field
• At least 1 year experience at Quva Pharma
• At least 2 years' experience in Quality Assurance, Sterile Compounding and/or GMP production facility
• At least 2 years' experience with FDA-regulated operations (cGMP processes)